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Anti-infective Agent

Test Drug for Bacterial Vaginosis

Phase 3
Waitlist Available
Research Sponsored by Balmoral Medical company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 21-30
Awards & highlights

Study Summary

This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with BV.

Eligible Conditions
  • Bacterial Vaginosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 21-30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 21-30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Cure

Side effects data

From 2018 Phase 3 trial • 871 Patients • NCT03091777
5%
Vulvovaginal mycotic infection
5%
Vulvovaginal candidiasis
2%
Abdominal pain
1%
Trichomoniasis
1%
Headache
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Test Drug
Vehicle Placebo Gel
Reference Drug

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Test DrugExperimental Treatment1 Intervention
GDC-229 gel applied vaginally as directed.
Group II: Reference DrugActive Control1 Intervention
Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Group III: Vehicle Placebo GelPlacebo Group1 Intervention
GDC-229 Vehicle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GDC-229
2017
Completed Phase 3
~880

Find a Location

Who is running the clinical trial?

Health DecisionsOTHER
30 Previous Clinical Trials
13,026 Total Patients Enrolled
Balmoral Medical companyLead Sponsor
3 Previous Clinical Trials
2,001 Total Patients Enrolled
Gage Development Company, LLCLead Sponsor
2 Previous Clinical Trials
1,901 Total Patients Enrolled
~106 spots leftby Jun 2025
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